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Misoprostol for Reduction of Blood Loss During Fibroid Surgery

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ClinicalTrials.gov Identifier: NCT02209545
Recruitment Status : Recruiting
First Posted : August 6, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Magdy Milad, MD, Northwestern University

Brief Summary:
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.

Condition or disease Intervention/treatment Phase
Fibroids Drug: Misoprostol Drug: Placebo Phase 4

Detailed Description:
This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial
Study Start Date : October 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Misoprostol
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
Drug: Misoprostol
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
Other Name: Cytotec

Placebo Comparator: Placebo
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Drug: Placebo
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Other Name: Vitamin B6 (pyridoxine)




Primary Outcome Measures :
  1. Estimated intra-operative blood loss [ Time Frame: Intra-operative ]
    Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.


Secondary Outcome Measures :
  1. Duration of procedure [ Time Frame: Intra-operative ]
    Intra-operative time

  2. Length of inpatient hospitalization [ Time Frame: Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively ]
    Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.

  3. Post-operative blood transfusion [ Time Frame: From time of surgery completion through discharge from hospital, an expected average period of 3 days ]
    Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
  • Age ≥ 18 years and ≤ 50 years
  • Pre-operative hemoglobin >8 g/dl
  • Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history
  • Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
  • Intraoperative use of vasopressin and uterine tourniquet is permissible
  • Can have had prior Cesarean delivery

Exclusion Criteria:

  • Patients who have had a prior abdominal myomectomy
  • Post-menopausal women
  • Patients with known bleeding/clotting disorders
  • Patients with a history of gynecologic malignancy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
  • Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209545


Contacts
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Contact: Magdy Milad, MD 312-472-4673 mmilad@nm.org
Contact: Megan Runge, MS megan.runge@northwestern.edu

Locations
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United States, Illinois
Northwestern University, Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Magdy Milad, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Magdy Milad, MD Northwestern University, Northwestern Memorial Hopsital

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Responsible Party: Magdy Milad, MD, Professor in Obstetrics and Gynecology, Reproductive Endo & Infertility, Northwestern University
ClinicalTrials.gov Identifier: NCT02209545     History of Changes
Other Study ID Numbers: STU00091259
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Magdy Milad, MD, Northwestern University:
fibroids, leiomyomata, blood loss, misoprostol
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Misoprostol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics